Fatal French clinical trial will see tighter safety guidelines introduced
Safety guidance for clinical trials is likely to be toughened and insurers need to be ready to respond. One volunteer died and five were hospitalised after taking part in a phase one trial for a new medicine manufactured by the Portuguese company Bial and tested by the French trial organiser Biotrial. The drug was intended for pain relief, anxiety and conditions such as Parkinson’s Disease. Although earlier volunteers had no ill effects, six later volunteers suffered brain injuries when the dose was escalated. Once the matter has been fully investigated, regulators will need to consider how best to increase doses and when to impose a maximum cap to safeguard the well-being of volunteers in future trials.
Product recall projection given government review
The independent UK Consumer Product Recall review by Lynn Faulds Wood was published in February 2016. It highlighted problems with traceability, consumer engagement and enforcement and asked how manufacturers and retailers could best reach consumers and ensure more respond. What about enforcement and the perception that rogue traders can still cut corners? Recommendations include setting up a central product safety agency, better funding of Trading Standards and reintroducing a national injury database to track injuries attributed to products. Without government support, new agencies or databases are unlikely. Expect instead a focus on how technology – including the Internet of Things – could help to trace recalled products, meaning that the system places less reliance on consumers acting on recall publicity.
Emissions scandal – manufacturers caught in the headlights
There will be greater scrutiny of manufacturers’ claims for their products as information continues to emerge about the VW emissions scandal, with litigation starting in the US and Germany. VW has agreed a buyback scheme in the US but this may not be enough to prevent further expensive litigation. Questions have been asked about other manufacturers and Mitsubishi has admitted issues with fuel economy data in Japan. However, this is not necessarily the peak of a spike in claims activity for insurers of manufacturers, in the absence of injury, damage or safety risk. Underwriters are likely to ask more questions about how manufacturers ensure compliance and how products are designed to pass official standards.
Key developments in 2015/16